Another step toward final call on Remdesivir efficacy as a treatment for hospitalized COVID-19 patients: a multicenter open-label trial
et al., medRxiv, doi:10.1101/2021.08.13.21261992 , Aug 2021
Single arm remdesivir trial with 145 hospitalized patients showing no statistically significant difference between "early" and "late" administration, however the treatment delays may be better described as late and very late. The text of the paper defines early and late as less than or more than 7 days from symptom onset, however the CONSORT diagram says during or after 7 days post admission.
Gérard, Zhou, Wu, Kamo, Choi, Kim show increased risk of acute kidney injury, Leo, Briciu, Muntean, Petrov show increased risk of liver injury, and Negru, Cheng, Mohammed show increased risk of cardiac disorders with remdesivir.
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Hosseini et al., 13 Aug 2021, preprint, 15 authors.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21261992; this version posted August 13, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC 4.0 International license .
Title: Another step toward final call on Remdesivir efficacy as a treatment for hospitalized
COVID-19 patients: a multicenter open-label trial
Running title: Remdesivir efficacy in COVID-19 treatment
Authors:
Hamed Hosseini1, Anahita Sadeghi2, Payam Tabarsi3, Azin Etemadimanesh4, Ilad Alavi
Darazam3, Nasser Aghdami4, Saeed Kalantari5, Mehrdad Hasibi4, Azar Hadadi4, Farhang
Babamahmoodi6, Mansooreh Momen-Heravi7, Ahmad Hormati8,9, Yunes Panahi10, Rozita
Khodashahi11, Mohammadreza Salehi4*
1. Center for Research and Training in Skin Disease and Leprosy, Tehran University of
Medical Sciences.
2. Department of Internal Medicine, Tehran University of Medical Sciences, Tehran, Iran.
3. Department of Infectious Disease, Shahid Beheshti University of Medical Sciences,
Tehran, Iran.
4. Department of Infectious Disease, Tehran University of Medical Science, Tehran, Iran.
5. Antimicrobial Resistance Research Center, Iran University of Medical Sciences, Tehran,
Iran
6. Antimicrobial Resistance Research Center, Communicable Diseases Institute,
Mazandaran University of Medical Sciences, Sari, Iran
7. Department of infectious diseases, faculty of medicine, Kashan university of medical
sciences, Kashan, Iran.
8. Gastroenterology and Hepatology Disease Research Center, Oom university of medical
sciences, Iran.
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21261992; this version posted August 13, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC 4.0 International license .
9. Gastrointestinal and Liver Diseases Research Center, Iran university of medical sciences,
Tehran, Iran.
10. Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical
Sciences, Tehran, Iran
11. Department of Infectious disease and tropical medicine, Faculty of Medicine, Mashhad
university of medical sciences, Mashhad, Iran.
Corresponding author:
Mohammadreza Salehi M.D., Department of Infectious Disease, Tehran University of Medical
Sciences. Imam Khomeini hospital complex, Gharib St., Tehran, Iran. Email:
salehi.mohamad3@gmail.com , ORCID: 0000-0002-1987-5929, Cellphone: +989123159842
Declaration of interests:
Hereby, all authors of this study declare no conflict of interests before, during, and after the
study was done.
Acknowledgments:
Our sincere thanks to Professor Reza Malekzadeh who coordinated and supervised the project.
We express our gratitude to the Digestive Diseases Research Institute (DDRI), Tehran University
of Medical Sciences. Conducting the study would not have been possible without the efforts of
the DDRI team. The authors also would like to express their gratitude for all care workers and
patients in study hospitals. This study has been funded and supported by Tehran University of
Medical Sciences (TUMS); Grant no. 99-1-97-47143.
medRxiv preprint doi:..
DOI record:
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"abstract": "<jats:title>Abstract</jats:title><jats:sec><jats:title>Introduction</jats:title><jats:p>After emerging the global pandemic of SARS-CoV2 some preliminary studies demonstrated the efficacy of antiviral treatments. But shortly thereafter, inconsistencies in the results of further clinical trials raised doubts on the efficacy of these agents. In this study, we aimed to evaluate the effect of Remdesivir on hospitalized COVID-19 patients’ outcomes.</jats:p></jats:sec><jats:sec><jats:title>Material and methods</jats:title><jats:p>This study was an open-label, single-armed, clinical trial on hospitalized patients diagnosed with COVID-19 who had progressive respiratory symptoms despite receiving standard care. All patients received Remdesivir and their characteristics, outcomes, time of treatment initiation, and respiratory support stages during hospitalization were registered and followed up for 14 days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>145 patients with the mean age of 52.89 ± 1.12 years enrolled in this study, 38 (26.2%) died at the end of 14 days period. The mean time interval from the onset of the symptoms to antiviral treatment was 10.63±0.56 days. Thirty deceased patients (78.9%) were men, showing 2.8 times higher mortality chance compared to women (OR<jats:sub>adj</jats:sub>=2.77; 95%CI=1.08-7.09). The type of respiratory support on the first day of treatment initiation showed a significantly lower mortality chance in patients receiving O<jats:sub>2</jats:sub>only than those who needed non-invasive and/or mechanical ventilation (OR<jats:sub>adj</jats:sub>=3.91; 95%CI=1.64-9.32). The start time (early vs late administration) and duration (less or more than 7 days) of antiviral treatment had no statistically significant association with mortality or ventilation escalation among the patients (p-value > 0.05).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>In this study, we showed that Remdesivir probably is not effective on the outcome of hospitalized COVID-19 patients.</jats:p></jats:sec>",
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Late treatment
is less effective
is less effective
